GE HealthCare Technologies, Inc. GEHC announced that it has received FDA approval for Flyrcado (flurpiridaz F 18), a breakthrough positron emission tomography myocardial perfusion imaging (PET MPI) agent for detecting coronary artery disease (CAD).
Flyrcado offers superior diagnostic accuracy for detecting CAD compared to traditional SPECT MPI, making it more accessible and convenient for challenging patient populations. This FDA approval represents a significant advancement in cardiac imaging, enabling more precise diagnostics for CAD,
CAD is the leading cause of death in the United States. Per Science Direct,CAD accounted for 695,000 deaths in 2021. The AURORA Phase III trial demonstrated that Flyrcado provided superior diagnostic accuracy for detecting coronary artery disease compared to both invasive coronary angiography and SPECT MPI.
Flyrcado is one of three FDA-approved F 18 imaging agents in GE HealthCare’s PET product portfolio. It joins Cerianna (fluoroestradiol F 18), used to detect estrogen receptor-positive lesions in breast cancer, and Vizamyl (flutemetamol F 18), a PET tracer forestimating beta-amyloid plaque density in patients being evaluated for Alzheimer’s or cognitive decline.
Likely Trend of GEHC Stock Following the News
Following the news, shares of GEHC rose 0.1% to $92.1 in the after-hours trading on Friday.
Shares of GE Healthcare have gained 11.7% year to date against the industry’s 8.3% decline. The S&P 500 has risen 20.3% in the same time frame.
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GE HealthCare is well-positioned for positive price performance following the FDA approval of Flyrcado. This milestone reinforces the company’s commitment to advancing personalized care and showcases its innovative capabilities in the healthcare sector. The approval is anticipated to enhance market sentiment and drive future growth, positioning GE HealthCare for potential stock gains.
Significance of GEHC’s Flyrcado PET Tracer FDA Approval
With Flyrcado’s approval, the company introduced the first F 18 PET MPI radiotracer for coronary artery disease, offering enhanced diagnostic efficacy compared to existing SPECT MPI.
The longer half-life, which is over 10 times longer than existing radiotracers of 109 minutes, allows distribution, eliminating the need for on-site production and generator maintenance. Flyrcado enables exercise stress testing with cardiac PET imaging for CAD, offering a more comprehensive evaluation of ischemia. This innovation expands access to PET MPI for hospitals and imaging centers, improving diagnostic accuracy, particularly for challenging patients such as those with high body mass index (BMI) or women. Flyrcado is expected to reshape nuclear cardiology by addressing unmet needs in CAD detection and offering a more robust, flexible diagnostic tool.
Flyrcado’s favorable properties, including its availability as a unit dose and the ability to facilitate exercise stress testing, are poised to significantly improve diagnostic confidence and meet critical patient needs in the field of molecular imaging.
More on Flyrcado PET Tracer
GE HealthCare secured exclusive global commercialization rights for flurpiridaz F 18 from Lantheus in 2017
Flyrcado, a PET tracer for coronary artery disease, is set to be launched in the U.S. market in early 2025, with availability expanding over time.
Market Prospects Favoring GEHC
Per a report in Future Market Insights, the PET scanners market size was worth $1.3 billion in 2023. It is anticipated to reach $2.1 billion by 2033 at a CAGR of 5.3%.
The robust growth is likely to be driven by the rising disease prevalence, particularly cancer and Alzheimer’s, driving demand for diagnostic tools in hospitals. PET scanners are widely used for detecting various cancers, while hybrid imaging systems and innovations like SiPM technology and TSPO PET tracers further boost market growth.
Zacks Rank & Key Picks
Currently, GE Healthcare carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the broader medical space are Universal Health Services UHS, ATI Physical Therapy (ATIP) and Aveanna Healthcare AVAH. While Universal Health Services sports a Zacks Rank #1 (Strong Buy), ATI Physical Therapy and Aveanna Healthcare carry a Zacks Rank #2 (Buy) each at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Universal Health Services has an estimated long-term growth rate of 19%. UHS’ earnings surpassed estimates in each of the trailing four quarters, with the average being 14.58%.
Universal Health Services has gained 41.1% compared with the industry’s 34.8% growth year to date.
ATI Physical Therapy’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 7.25%.
ATIP’s shares have gained 5.5% year to date compared with the industry’s 18.6% growth.
Aveanna Healthcare’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 47.5%.
AVAH’s shares have surged 104.5% year to date compared with the industry’s 15.7% growth.
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